Clinical trials: Vascular Surgery
Thromboembolism, Arthroplasty, Replacement, Hip
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in…
- Trial name
- NCT00168818
- Testing
- dabigatran etexilate, enoxaparin
- Where
- 116 sites in Australia, Austria and 14 more
- Volunteers
- 3,494 people
- Sponsor
- Boehringer Ingelheim
Arteriovenous Graft
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in extending the duration of primary patency after arteriovenous graft surgery in subjects with end-stage renal disease.
- Trial name
- NCT01806584
- Testing
- SRM003, Participating Site's standard practice
- Where
- 46 sites in United States
- Volunteers
- 32 people
- Sponsor
- Shire
Hypertension
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of blood pressure in cardiac surgery patients, as well…
- Trial name
- SPRINT (NCT00799604)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- The Medicines Company
Venous Thromboembolism
Prevention of Venous Thromboembolic Events After Elective Orthopaedic Surgery in Patients Treated With PRADAXA
Observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for Total Knee Replacement or Total Hip Replacement iin patients treated with PRADAXA to evaluate the efficacy ant…
- Trial name
- NCT01139658
- Where
- 53 sites in France
- Volunteers
- 1,676 people
- Sponsor
- Boehringer Ingelheim
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease
EXCEL Clinical Trial
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with…
- Conditions
- Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205776)
- Testing
- Percutaneous Coronary Intervention, CABG
- Where
- United States
- Volunteers
- 1,905 people
- Sponsor
- Abbott Medical Devices
Thromboembolism
Hip Fracture Study of GSK576428 (Fondaparinux Sodium)
This study is requested by PMDA to confirm the efficacy and the safety for HFS.
- Trial name
- NCT00320424
- Testing
- Fondaparinux
- Volunteers
- 48 people
- Sponsor
- GlaxoSmithKline
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Venous Thromboembolism
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
- Trial name
- NCT01181141
- Testing
- DU-176b (edoxaban), Enoxaparin sodium 20mg
- Where
- Japan
- Volunteers
- 92 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Myocardial Ischemia, Acute Coronary Syndrome
EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)
The purpose of this study is to see if early INTEGRILIN® (eptifibatide) therapy in patients with non-ST-segment elevation acute coronary syndrome (ACS) reduces the occurence of death, heart attack and urgent cardiac intervention…
- Trial name
- NCT00089895
- Testing
- Eptifibatide (Integrilin)
- Volunteers
- 9,406 people
- Sponsor
- Organon and Co
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.
Complications
Femoral Micropuncture or Routine Introducer Study
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood…
- Trial name
- FEMORIS (NCT01103141)
- Testing
- Micropuncture needle set, Standard gauge-18 needle set
- Where
- 2 sites in United States
- Volunteers
- 143 people
- Sponsor
- Cook Group Incorporated
Deep Vein Thrombosis, Coronary Artery Bypass Surgery
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis
This trial is a prospective, single-center Phase II randomized study to demonstrate the superior efficacy of Fondaparinux Sodium subcutaneous injections in patients undergoing CABG surgery (isolated and redo isolated) versus…
- Conditions
- Deep Vein Thrombosis, Coronary Artery Bypass Surgery, Venous Thromboembolism
- Trial name
- NCT00789399
- Testing
- Fondaparinux
- Volunteers
- 78 people
- Sponsor
- Prairie Education and Research Cooperative
Carotid Artery Stenosis
ViVEXX Carotid Revascularization Trial (VIVA)
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid…
- Trial name
- NCT00417963
- Testing
- Carotid Artery Stenting
- Volunteers
- 407 people
- Sponsor
- C. R. Bard
Coronary Artery Disease
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either…
- Trial name
- SYNTAX (NCT00114972)
- Testing
- Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent, Coronary Artery Bypass Surgery
- Where
- 106 sites in United States, Austria and 16 more
- Volunteers
- 1,800 people
- Sponsor
- Boston Scientific Corporation
Surgical Wound
VASCADE ANTEGRADE-PVD Post-Market Registry
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional…
- Trial name
- NCT02948257
- Testing
- Cardiva Medical VASCADE VCS
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Cardiva Medical, Inc.
Diabetic Foot Ulcer, Surgical Wound
The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
A Multicentre Randomized Controlled Trial to Investigate the Effect of Natrox Topical Oxygen Wound Therapy on the Healing rates of Diabetic Foot Ulcers.
- Trial name
- NCT03905863
- Testing
- Natrox® Oxygen Wound Therapy
- Where
- 20 sites in United States, Puerto Rico
- Volunteers
- 145 people
- Sponsor
- Inotec AMD Limited
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Elevated Cardiac Risk, Coronary Arteries Disease Risk
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon based general anesthesia procedure in patients with…
- Trial name
- CARVASAXe (NCT01120405)
- Testing
- Xenon, Sevoflurane
- Where
- 13 sites in France
- Volunteers
- 600 people
- Sponsor
- Air Liquide Santé International
Arthroplasty, Replacement, Knee, Venous Thrombosis
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism…
- Trial name
- NCT00246025
- Testing
- Dabigatran etexilate
- Where
- 38 sites in Japan
- Volunteers
- 512 people
- Sponsor
- Boehringer Ingelheim
Vascular Anastomosis Surgery
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03103282
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 65 people
- Sponsor
- 3-D Matrix Europe SAS